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NCT05469893 · ClinicalTrials.gov registry record · Phase 2
Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
A Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma, sponsored by Irene Ghobrial, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 3
- Study locations
NCT05469893: Recruiting Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma, sponsored by Irene Ghobrial, MD.
NCT05469893 is a Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma that is actively recruiting participants, run by Irene Ghobrial, MD. The registered enrollment target is 52 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05469893, a Phase 2 study of Multiple Myeloma and Smoldering Multiple Myeloma, is actively recruiting participants, sponsored by Irene Ghobrial, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma. People with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressing to active multiple myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which are an important part of the immune system. Patients with active multiple myeloma generally require treatment but there are currently no approved therapies for smoldering multiple myeloma. The names of the study drugs involved in this study are: * Teclistamab * Lenalidomide (also called Revlimid) * Dexamethasone (also called Decadron)
Primary Outcome
The complete response rate (CRR) was defined as the proportion of participants achieving complete response (CR) based on International Myeloma Working Group (IMWG) Response criteria. CR defined as requires all of the following: * Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks by immunofixation studies. * \<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks. * No increas
Conditions Studied
Interventions
- DRUG Teclistamab
- DRUG Dexamethasone
- DRUG Lenalidomide
Study Locations (3)
Colorado
- Colorado Blood Cancer Institute - Denver
Massachusetts
- Dana Farber Cancer Institute - Boston
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2030-07-31 |
| Phase | Phase 2 |
What NCT05469893 shows while recruiting
NCT05469893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Teclistamab is the first listed.
NCT05469893 reports a single indexed study location in Colorado, Massachusetts, Oregon.
Frequently Asked Questions
What is clinical trial NCT05469893 about?
NCT05469893 is a clinical study titled "Immuno-PRISM (PRecision Intervention Smoldering Myeloma)". The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma. People with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressi...
What is the current status of trial NCT05469893?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2022-08-10. Estimated completion is 2030-07-31.
What conditions does trial NCT05469893 study?
This clinical trial studies the following conditions: Multiple Myeloma, Smoldering Multiple Myeloma, High-risk Smoldering Multiple Myeloma.
What interventions are being tested in trial NCT05469893?
The interventions under investigation include: Teclistamab (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT05469893?
This trial is sponsored by Irene Ghobrial, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05469893 being conducted?
This trial has 3 study locations across Colorado, Massachusetts, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05469893's enrollment target sits among peer trials
52 245th of 438 higher than 189 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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